Blog

USP Class VI
USP Class VI: New Approach to Polymer Safety in Medical Devices
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For decades, many medical device manufacturers have relied on USP Class VI certification when selecting...
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Food supplement products can be novel or non-novel food, regardless of its ingredient.
Novel Food in Ingredients and Food Supplements: Key Differences
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Did you know that in the EU an ingredient can be classified as a Novel...
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Regulation (EU) 2026/405 shifts detergents compliance into...
Regulation EU 2026/405: New Detergents and Surfactants Compliance
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Regulation (EU) 2026/405 is the new European Union regulation on detergents and surfactants, published in...
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February Regulatory Updates
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Biocides: BPC approves Ethanol use for disinfectants and hand sanitizers On February 24 in Helsinki,...
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Permitted Daily Exposure
Permitted Daily Exposure within EMA and ICH Framework
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Permitted Daily Exposure (PDE, also referred to as “permissible daily exposure”) is a health-based limit...
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EUDAMED is Now Mandatory: What has changed since May 2026
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The European Database on Medical Devices, a key element of the European Union’s regulatory framework...
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PFAS: Compliance of the “Forever Chemicals”
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What are PFAS?  The large family of synthetic substances is characterized by the presence of...
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January Regulatory Updates
Medical Devices: FDA’s SaMD Clinical Evaluation Guidance withdrawn The FDA revised its guidelines in 2026...
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EFSA Food Additives
EFSA’s New Guidance on Food Additives: What You Need to Know
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In the European Union, food additives can be used in food and beverages only if...
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CER and CEP with ISO 18969
ISO 18969 Clinical Evaluation: Key Changes to Know
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Clinical evaluation remains one of the most critical and challenging elements of medical device compliance....
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